Cancer, Neoplasms
Conditions
Brief summary
This study will collect further basic safety data on participants with cancer treated with enzastaurin. This study is not open to the public. The purpose of the this study is to extend the clinical experience of participants who complete enzastaurin therapy per clinical pharmacology and biopharmaceutics studies conducted by Eli Lilly and Company and who may benefit from continued enzastaurin therapy.
Interventions
DRUGenzastaurin
500 milligrams (mg), oral, daily, six 42-day cycle and subsequent cycles or until participants met study discontinuation criteria of progressive disease or unacceptable toxicity
Sponsors
Eli Lilly and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* You must have previously participated in and finished Study H6Q-LC-JCAV (JCAV), Study H6Q-LC-JCAY (JCAY), or other enzastaurin clinical pharmacology and biopharmaceutics studies. If you have had any other cancer treatment (chemotherapy, radiation, anti-cancer hormone therapy), you must have completed it at least 4 weeks ago before you can enroll in this study. * You must have a cancer for which no other therapy exists that can prolong your life. This may include participants with treated, stable brain cancer. * You must have lesions (areas of cancer in your body) that your doctor can either measure or detect. * You either must not be able to become pregnant, (because you've had surgery \[tubes tied or hysterectomy\], you've gone through menopause, or you've had previous radiation for cancer that made you sterile) or your potential to become pregnant must be reduced by the use of an approved birth control method (including intrauterine or barrier devices) during and for 3 to 6 months following the study. * You can be either male or female, and must be at least 18 years old.
Exclusion criteria
* You must not have received treatment within the last 30 days with a drug other than enzastaurin that is still experimental (this means it has not received approval to be prescribed, except in a clinical trial). * You must not be pregnant or breastfeeding. * You must not have central nervous system (CNS) tumors (tumors in your brain and spinal cord). (However, participants who have stable CNS tumors and are taking steroid medication may be included.) * You must not have another serious disorder, including active infections that will interfere with your participation in the study. * You must not have a second cancer in addition to your primary cancer. Participants with adequately treated skin cancer or who have had another cancer in the past, but have been cancer free for more than 2 years, are eligible.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With 1 or More Adverse Events (AEs) or Any Serious AEs | Baseline through study completion (up to 26 months and 30-day safety follow-up) | Data presented are the number of participants who experienced 1 or more AEs or any serious AEs (SAEs) regardless of causality. A summary of SAEs and other non-serious AEs is located in the Reported Adverse Events section of this report. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Disease Progression (Time to Documented Tumor Activity) | Baseline through study completion (up to 26 months and 30-day safety follow-up) | Time to disease progression was defined as the time in months from study enrollment to the first date of progressive disease. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. Progressive Disease was defined as having at least a 20% increase in sum of the longest diameter of target lesions. Time to disease progression was censored at the date of the last follow-up for participants who did not experience progressive disease, death, or their disease status was unknown. |
| Percentage of Participants With Best Overall Response (Documented Antitumor Activity) | Baseline through study completion (up to 26 months and 30-day safety follow-up) | Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. Complete Response was defined as the disappearance of all target lesions. Partial Response was defined as having at least a 30% decrease in sum of longest diameter of target lesions. Progressive Disease was defined as having at least a 20% increase in sum of longest diameter of target lesions. Stable Disease was defined as small changes that did not meet the above criteria. Also, reported were unknown and missing responses. Percentage of participants was calculated as the total number of participants affected divided by the number of participants analyzed then multiplied by 100. |
Countries
United States
Participant flow
Pre-assignment details
Eligible participants must have completed other enzastaurin clinical pharmacology studies to meet the enrollment criteria for the study.
Participants by arm
| Arm | Count |
|---|---|
| Enzastaurin Enzastaurin 500 milligrams (mg) per day, administered orally as five 100-mg tablets or four 125-mg tablets, once daily for 42 days (1 cycle = 42 days) and subsequent cycles. Treatment was continued until disease progression, unacceptable toxicity, or any other discontinuation criteria were met. | 23 |
| Total | 23 |
Baseline characteristics
| Characteristic | Enzastaurin |
|---|---|
| Age, Continuous | 60.0 years STANDARD_DEVIATION 12.1 |
| Disease Stage at Initial Pathological Diagnosis Stage I | 1 Participants |
| Disease Stage at Initial Pathological Diagnosis Stage II | 2 Participants |
| Disease Stage at Initial Pathological Diagnosis Stage IIA | 2 Participants |
| Disease Stage at Initial Pathological Diagnosis Stage IIB | 1 Participants |
| Disease Stage at Initial Pathological Diagnosis Stage IIC | 1 Participants |
| Disease Stage at Initial Pathological Diagnosis Stage III | 3 Participants |
| Disease Stage at Initial Pathological Diagnosis Stage IV | 13 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status Score 0 | 7 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status Score 1 | 13 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status Score 2 | 3 Participants |
| Initial Pathological Diagnosis Locally Advanced | 5 Participants |
| Initial Pathological Diagnosis Metastatic | 16 Participants |
| Initial Pathological Diagnosis Other (Unspecified Cancer Diagnosis) | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 3 Participants |
| Race/Ethnicity, Customized Caucasian | 20 Participants |
| Region of Enrollment France | 10 Participants |
| Region of Enrollment United States | 13 Participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 19 / 23 |
| serious Total, serious adverse events | 9 / 23 |
Outcome results
Primary
Number of Participants With 1 or More Adverse Events (AEs) or Any Serious AEs
Data presented are the number of participants who experienced 1 or more AEs or any serious AEs (SAEs) regardless of causality. A summary of SAEs and other non-serious AEs is located in the Reported Adverse Events section of this report.
Time frame: Baseline through study completion (up to 26 months and 30-day safety follow-up)
Population: All enrolled participants who received at least 1 dose of enzastaurin.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Enzastaurin | Number of Participants With 1 or More Adverse Events (AEs) or Any Serious AEs | AEs | 19 Participants |
| Enzastaurin | Number of Participants With 1 or More Adverse Events (AEs) or Any Serious AEs | SAEs | 9 Participants |
Secondary
Percentage of Participants With Best Overall Response (Documented Antitumor Activity)
Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. Complete Response was defined as the disappearance of all target lesions. Partial Response was defined as having at least a 30% decrease in sum of longest diameter of target lesions. Progressive Disease was defined as having at least a 20% increase in sum of longest diameter of target lesions. Stable Disease was defined as small changes that did not meet the above criteria. Also, reported were unknown and missing responses. Percentage of participants was calculated as the total number of participants affected divided by the number of participants analyzed then multiplied by 100.
Time frame: Baseline through study completion (up to 26 months and 30-day safety follow-up)
Population: All enrolled participants who received at least 1 dose of enzastaurin.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Enzastaurin | Percentage of Participants With Best Overall Response (Documented Antitumor Activity) | Complete Response | 0 percentage of participants |
| Enzastaurin | Percentage of Participants With Best Overall Response (Documented Antitumor Activity) | Partial Response | 0 percentage of participants |
| Enzastaurin | Percentage of Participants With Best Overall Response (Documented Antitumor Activity) | Stable Disease | 34.8 percentage of participants |
| Enzastaurin | Percentage of Participants With Best Overall Response (Documented Antitumor Activity) | Progressive Disease | 52.2 percentage of participants |
| Enzastaurin | Percentage of Participants With Best Overall Response (Documented Antitumor Activity) | Unknown Response | 4.3 percentage of participants |
| Enzastaurin | Percentage of Participants With Best Overall Response (Documented Antitumor Activity) | Missing Response | 8.7 percentage of participants |
Secondary
Time to Disease Progression (Time to Documented Tumor Activity)
Time to disease progression was defined as the time in months from study enrollment to the first date of progressive disease. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. Progressive Disease was defined as having at least a 20% increase in sum of the longest diameter of target lesions. Time to disease progression was censored at the date of the last follow-up for participants who did not experience progressive disease, death, or their disease status was unknown.
Time frame: Baseline through study completion (up to 26 months and 30-day safety follow-up)
Population: All enrolled participants who received at least 1 dose of enzastaurin. Two (2) participants were censored.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Enzastaurin | Time to Disease Progression (Time to Documented Tumor Activity) | 1.4 months |